Are You Compliant?

WangLevensonLast month we discussed the 2004 JCAHO Environment of Care (EC) standards, especially the Elements of Performance (EPs) 3 and 4 of EC.6.20. We cannot help you solve your EP4 woes (missing inspection of less than three pieces of equipment within “an average sample size of 10"—do not ask us what that means) since we have no wish to be jailed for preaching civil disobedience or “creative” equipment inventory. However, we do have suggestions to help you deal with EP3 (managing life-support equipment).

Some colleagues have suggested three steps to ensure compliance with EP3: 1) create a separate inventory for life-support equipment; 2) establish a maintenance plan for each type of equipment; and 3) document the maintenance for each unit. As discussed last month, the challenges are the potentially many additional devices that would necessarily be included and inspected. To reduce the number of units, some colleagues have proposed adopting a very restrictive definition of life-support equipment. Using the proposals that were made before, we suggest defining a life-support device as one “designed to sustain life and whose failure to perform its primary function, when used according to manufacturer’s instructions and clinical protocol, is expected to result in imminent death in the absence of prompt intervention."

Large numbers of devices that fit this definition are traditionally (and with good reason) excluded from most medical equipment management plans (MEMPs), however. For example, in addition to ventilators and intra-aortic balloon pumps typically included in MEMPs, this definition includes less-sophisticated devices, such as external pacemakers, suction pumps, oxygen pressure regulators, and oxygen flowmeters (the last two for oxygen-dependent patients).

Fortunately, EP3 was classified by JCAHO as “category A" for scoring purposes (ie, scoring is based on the existence of policies and plans), and so we believe it is possible to fulfill the requirement using the following steps:

1) Include “life support" explicitly among the criteria used to determine whether a piece of equipment should be incorporated in the MEMP. One possibility would be to add “life support" to the four classes (diagnosis, care, treatment, and monitoring) cited by JCAHO as “equipment function"—although we still prefer to reinterpret equipment function as “mission critical" as we have proposed before1. A better alternative is to explicitly define “life support” as one of the “physical risks associated with use," as many organizations, including ECRI, have advocated.

2) After including the criterion “life support” in the MEMP decision process, continue to manage medical equipment according to the MEMP. In other words, do what you

have always done, include a device in MEMP if its total score is higher than your chosen threshold, etc. This process should preserve equipment that genuinely requires periodic safety and performance inspections (SPIs) (eg, ventilators and heart-lung bypass machines) but eliminates simple devices, such as oxygen pressure regulators, oxygen flowmeters, and the like, that are highly reliable and whose failure can be easily detected before their use on patients.

3) Document the SPI of life-support equipment in the same fashion as for all equipment in MEMP.

Our proposal absolves each organization from creating an additional (and burdensome) inventory system for life-support equipment and performing SPIs on many devices for which they are not truly needed. The time thus saved can be used for sorely needed user training and for providing valuable feedback to manufacturers. In many hospitals, this proposal can be accomplished by simply revising the current inclusion criteria database to explicitly consider life support (if it is not already) or updating its computerized maintenance management system (CMMS).

We realize that this proposal is limited since it does not really address the central issue of how to increase patient safety while making us more productive. To achieve this goal, we strongly believe the clinical engineering community should join forces and “write" a new set of equipment standards for JCAHO, instead of complaining and finding artificial and ineffective ways to comply with standards with which we do not agree. If enough broad-based support can be garnered, it will be difficult for JCAHO to ignore a grassroots movement that genuinely puts patient safety and organization efficiency above mere code compliance.

Binseng Wang is vice president of quality assurance and regulatory affairs at MEDIQ, Pennsauken, NJ.

Alan Levenson is an equipment planning consultant at New York Presbyterian Hospital, New York City.

1. Wang B, Levenson A. Equipment inclusion criteria—a new interpretation of JCAHO’s medical equipment management standard. J Clin Eng. 2000;25(1):26-35.